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Long-term efficacy of opicapone in fluctuating Parkinson's disease patients: A pooled-analysis of data from two Phase 3 clinical trials and their open-label extensions

European Journal of Neurology Jan 31, 2019

Ferreira JJ, et al. - Researchers assessed the effectiveness of the catechol-O-methyltransferase (COMT) inhibitor, opicapone (25 mg and 50 mg), as adjunct therapy to levodopa in a pooled population of patients with Parkinson's disease who partook in the pivotal double-blind trials of opicapone and their 1-year open-label extensions. For this investigation, they combined data (placebo, opicapone 25 mg, and opicapone 50 mg) from the BIPARK 1 and 2 double-blind and open-label studies. They found that the mean treatment effect vs placebo was -35.1 minutes for the 25-mg dose and -58.1 minutes for the 50-mg dose. Overall, opicapone consistently reduced OFF-time and increased ON-time over at least 1 year of open-label therapy without increasing the frequency of troublesome dyskinesia.

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